DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-7, 10-16 are pending.
Claims 10-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/17/2024.
Claims 1-7 are examined herein as they read on the elected subject matter.
Priority
As indicated in the previous Office action and reiterated below for convenience, the effective filing date of the claimed invention is 03/02/2018, the filing date of the PCT/US2018/020762 application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 62/466961 and Application No. 62/551732, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claims require a guide RNA that does not comprise a recruiting domain that is recognized by an ADAR enzyme wherein an ADAR enzyme present in a cell, when contacted by the guide RNA and the target RNA, results in deamination of the target adenosine in the target RNA (see claim 1). Application No. 62/466961 does not appear to disclose ADAR enzyme at all, let alone deamination of a target adenosine in a target RNA when the ADAR enzyme contacts the guide RNA and target RNA. Although Application No. 62/551732 discloses deamination of adenosine in a target RNA when a ADAR enzyme in a cell is contacted with a gRNA and the target RNA, Application No. 62/551732 does not appear to disclose that the guide RNA does not comprise a recruiting domain that is recognized by an ADAR enzyme. Application No. 62/551732 only appears to disclose a guide RNA with 1 or 2 ADAR recruiting domains and does not appear to disclose a guide RNA without any ADAR recruiting domain. It is noted that PCT/US2018/020762 filed 03/02/2018 does disclose a guide RNA with “optionally, one or two recruiting domains (also referred to as aptamers) that recruit RNA binding domains of various proteins, The optional recruiting domains located…” in paragraph [0203].
Thus, the effective filing date of the claimed invention is 03/02/2018, the filing date of the PCT/US2018/020762 application.
Should Applicant traverse, they are asked to provide the specific location in the prior applications where support can be found, such as by identifying the specific page (or paragraph) and lines, or Figure, where support can be found.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,932,856. Although the claims at issue are not identical, they are not patentably distinct from each other, essentially for the reasons of record as updated below.
The instant claims are described in the rejection above.
The claims of the ‘856 patent are drawn to a pharmaceutical composition in unit dose form comprising: (a) a DNA vector encoding a guide RNA, wherein the guide RNA: (i) comprises an antisense region that hybridizes to a target RNA, and (ii) has two recruiting domains or no recruiting domains, wherein the two recruiting domains are recognized by an adenosine deaminase acting on RNA (ADAR) enzyme, and (b) a pharmaceutically acceptable excipient, diluent, or carrier… wherein an endogenous ADAR enzyme present in endogenous amounts in a cell, when contacted with the guide RNA and the target RNA, deaminates an adenosine in the target RNA, and wherein the guide RNA, by leveraging endogenous ADAR enzyme in endogenous amounts, results in reduced off-target editing relative to pharmaceutical compositions that encode or contain exogenously added ADAR enzyme (see claim 1; emphasis added). Claim 2 indicates that the antisense region and the target RNA form a mismatch corresponding to a cytosine of the antisense region and the adenosine of the target RNA. Claim 13-14 indicate that the target RNA comprises a nonsense or missense mutation implicated in diseases including muscular dystrophy.
The major difference between the instant claims and the claims of the ‘856 patent are that the instant claims are drawn to a composition comprising the gRNA that lacks an ADAR recruiting domain, while the claims of the patent are drawn to a composition comprising a DNA vector encoding the gRNA including a gRNA that lacks ADAR binding domains. Although the instant claims differ from the patented claims, the difference is between a DNA vector encoding a gRNA and the gRNA itself. Both sets of claim encompass a gRNA that can be used to facilitate deamination of an adenosine residue in a target RNA using an ADAR enzyme, while one set of claims is drawn to a DNA vector encoding the gRNA and the other set of claims is drawn to the gRNA. There is no patentable difference between a DNA encoding a gRNA and the gRNA itself, which is the case here. Nevertheless, using the specification of the ‘856 patent as a dictionary to define the obvious variations of the patented claims, it is clear that the specification disclose a composition comprising a gRNA encompassed by the instant claims where the gRNA does not have an ADAR recruiting domain (e.g., see column 6, line 62 through column 7 line 20; column 54, lines 31-48). Regarding the claimed requirements that the gRNA targets opal, amber, or ochre stop codons, the specification of the issued patent defines the gRNA as encompassing ones that target the mutations (e.g., see column 5, lies 50-54, column 6, lines 10-15). Furthermore, regarding instant claims 8 and 9, which require that the gRNA comprise a chemical modification, including a 2’-O-methyl modification, it is noted that the specification of the ‘856 patent defines the guide RNA as encompassing 2’-O-methyl modifications (e.g., see column 3, lines 45-50). It is also noted that the examined application is a child application that claims priority to, and has a disclosure that is identical to the disclosure of the application from which the ‘856 patent issued. Accordingly, the claimed invention is an obvious variation of the invention claimed in the ‘856 patent.
MPEP 804 II B 1 states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)… Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
Response to Arguments
With respect to the priority issue, Applicant submits that the disclosures describe using adRNA and radRNA constructs in both the PCT and priority documents.
This is not persuasive because as previously indicated, only the PCT application appears to support the recruiting domains as being optional, the other priority documents only appear to disclose having the recruiting domain(s). Furthermore, it is noted that Applicant did not indicate where support for the present claimed invention with no recruiting domains can be found in the priority documents.
With respect to the rejection of claims under 35 USC 102, Applicant’s argument, in view of the amendment to the claims, is persuasive. Therefore the rejection is withdrawn.
Applicant's arguments with respect to the Double Patenting rejection(s) have been fully considered but they are not persuasive. Applicant argues that the Office has not shown that the referenced claims contain all of the limitations of claim 1 and dependent claims. This is not persuasive because the rejection does address all of the limitations of claim 1 and dependent claims, as previously indicated and reiterated above. Therefore, the double patenting rejection is maintained as applicants have not filed a terminal disclaimer or otherwise overcome the rejection.
Relevant Art
Katrekar et al. (Nat. Methods (2019) March; 16(3):239-242), is a reference published after the instant application was filed and includes the inventors of this application as authors. Katrekar et al. provides surprising evidence that a guide RNA with no ADAR recruiting domains are able to recruit endogenous ADAR present in endogenous amounts in the cell (see supplementary Figure 2b). It is noted that Applicants discussed the surprising evidence present in Katrekar et al. in communications filed in prior application 16/490494 (e.g., see communication filed 09/06/2023 in 16/490494).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637